Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Advanced Surgical Concepts · Predicate Candidate Screening

9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

128 daysmedian FDA review time
244 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K232701Guardenia (GAR-1)Advanced Surgical Concepts2023-09-29240
K192898PneumoLinerAdvanced Surgical Concepts2020-02-251370
K121309ASC QUADPORT + LAPAROSCOPIC ACCESS DEVICEAdvanced Surgical Concepts2012-09-061280
K111407TRIPORT, TRIPORT+, TRIPORT15, QUADPORTAdvanced Surgical Concepts2012-01-182440
K110004ASC TRIPORT+ LAPAROSCOPIC ACCESS DEVICEAdvanced Surgical Concepts2011-01-26230
K101794ASC TRIPORT LAPAROSCOPIC ACCESS DEVICE MODEL TPRT-02-01 (WA5Advanced Surgical Concepts2010-11-291540
K073719ASC TRIPORT LAPAROSCOPIC ACCESS DEVICEAdvanced Surgical Concepts2008-01-29290
K073170R-PORT II LAPAROSCOPIC ACCESS DEVICEAdvanced Surgical Concepts2007-12-03240
K070158R-PORT LAPAROSCOPIC ACCESS DEVICEAdvanced Surgical Concepts2007-08-232180

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda